Actively Recruiting

Age: 40Years - 60Years
FEMALE
Healthy Volunteers
ID07136220

A Pilot Study to Evaluate Equol and Its Effects on Menopausal Symptoms Experienced by Women in Singapore

Led by Ang Seng Bin · Updated on 2025-08-22

300

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

A

Ang Seng Bin

Lead Sponsor

O

Otsuka Pharmaceutical Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate the effect of equol, a compound produced by gut bacteria from soy-related diets, on menopausal symptoms in women aged 40 to 60. The study hypothesizes that women who produce equol may experience milder menopausal symptoms compared to those who do not. Equol has estrogen-like activity, which is thought to influence these symptoms. Participants will consume a soy protein bar after dinner on the first day of the study. Urine samples will be collected before and after consuming the soy bar to measure equol concentration. The samples will be analyzed to assess the relationship between equol production and menopausal symptoms. During the study, participants will have their height, weight, and blood pressure measured and will complete questionnaires about their demographics, menopausal symptoms, diet, and physical activity. Urine samples will be collected on two consecutive mornings and sent for analysis. The main outcome measured is the urine equol concentration before and after soy bar consumption, helping researchers understand equol's role in menopausal symptoms.

CONDITIONS

Brief Title

A Pilot Study to Evaluate Equol and Its Effects on Menopausal Symptoms Experienced by Women in Singapore

Who Can Participate

Age: 40Years - 60Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 40-60
Not Eligible

You will not qualify if you...

  • Pregnant women
  • Allergy to Soy
  • Allergy to nuts
  • Consumed antibiotics within 7 days of the study
  • Has a history of autoimmune diseases
  • Has a history of thyroid disease
  • On medical treatment with hormone therapy, elective oestrogen receptors modulators
  • Consuming equol-containing supplements or food
  • Consuming painkillers
  • Consuming anti-depressants and/or sleeping pills

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - 2 days

Participants provide baseline information and samples including height, weight, blood pressure, and questionnaires about menopausal symptoms and lifestyle. First morning urine sample is collected before consuming a soy protein bar.

2 visits (in-person and sample collection)

Monitoring

Duration - 2 days

Participants consume a soy protein bar after dinner on Day 1 and collect a second first morning urine sample the next day for analysis of urinary equol concentration.

1 visit (in-person) and 2 urine sample collections

Trial Site Locations

Total: 1 location

1

KK Women's and Children's Hospital

Singapore, Singapore

Actively Recruiting

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Research Team

S

Seng Bin Dr Ang

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Prevalence of the equol-producer phenotype and its relationship with dietary isoflavone and serum lipids in healthy Chinese adults.

Baohua Liu, Liqiang Qin, Aiping Liu...

https://pubmed.ncbi.nlm.nih.gov/20671375